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. 2020 Jun 4;2020(6):CD012431. doi: 10.1002/14651858.CD012431.pub2

Little 2013a.

Study characteristics
Methods Clinical setting: general practices
Single‐ or multicentre study: multicentre
Country of study: United Kingdom
Unit of allocation: individual participants
Inclusion criteria: people aged ≥ 3 years presenting with acute sore throat (2 weeks or less of sore throat) and an abnormal looking throat (erythema and/or pus)
Exclusion criteria: non‐infective causes of sore throat and inability of participant or parent/guardian to consent
Follow‐up:

  1. participants completed a symptom diary each night until symptoms resolved or up to 14 nights. Each symptom was scored (0 = no problem to 6 = as bad as it could be): sore throat, difficulty swallowing, feeling unwell, fevers, sleep disturbance. Participants took their temperature with a disposable thermometer;

  2. if a diary was not received by 3 weeks, a brief questionnaire was sent to document key outcomes, and then a telephone call if the brief questionnaire was not received;

  3. notes were reviewed to document subsequent episodes of infection, time to return for these episodes, complications, and economic data;

  4. the available follow‐up time varied from 1 month to 2 years.
Participants Number of clusters (n): not applicable
Number of participants (n): 424 (as in Table 1 of the article)
Participant characteristics:

  1. age (distribution): mean age in years (SD) 31 (17) in Group 2 and 29 (17) in Group 3;

  2. female participants (%): 62.8%;

  3. clinical severity distribution of Centor/McIsaac score: not reported.
Interventions Management in intervention group(s): RADT in combination with clinical examination/scoring system (“Group 3”: clinical score 0 to 1, no antibiotics or rapid antigen test; score of 2, delayed antibiotic prescription without rapid testing; scores ≥ 3, rapid antigen test with antibiotics not offered if negative result).
Type of RADT system used: enzyme immunoassay
Commercial name and brand of the RADT: IMI TestPack Plus Strep A (Inverness Medical)
Management in control group(s): clinical grounds with a scoring system (“Group 2”: clinical score 0 to 1, no antibiotics; score 2 to 3, delayed antibiotics; score ≥ 4, immediate antibiotics).
Outcomes Primary outcome(s): symptom severity (mean score of soreness and difficulty swallowing in days 2 to 4)
Secondary outcome(s):

  1. duration of moderately bad symptoms;

  2. use of antibiotics;

  3. belief in need to see doctor in future;

  4. return to the surgery;

  5. suppurative complications.
Notes Type of report: journal article
Source(s) of funding: funded by the National Institute for Health Research Heath Technology Assessment (HTA) Programme (project
number 05/10/01)
RCT registration number: ISRCTN32027234
The PRISM RCT had 2 parts, each relying on a different clinical scoring system. The results of the first part of the trial, obtained with Score 1, are presented in the online appendices (and here referred to as Little 2013b). The results of the second part of the trial, obtained with Score 2 (acronym FeverPAIN), are presented in the text as the main findings (and here referred to as Little 2013a). We assumed that the methods were similar for the 2 parts of the trial.
The “Delayed antibiotics” group (“Group 1”) was excluded because by definition all participants were prescribed antibiotics.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were individually randomised with a web based computer randomisation service to one of three groups. [...] Randomisation used permuted block sizes of 3, 6, 9, and 12, which were also randomly chosen."
Allocation concealment (selection bias) Low risk Web‐based computer randomisation
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding is impossible in this context, and this lack of blinding is likely to influence the outcome.
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding is impossible in this context, and this lack of blinding is likely to influence the outcome.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk There are discrepancies between participants included in the initial assessments and in the follow‐up (20% to 25% reduction in participants assessed for the outcome “antibiotic use” compared to initial number of participants), without any explanation.
Selective reporting (reporting bias) Low risk All outcomes mentioned in the Methods section are presented in the Results section. There is concordance between protocol and article.
Other bias Low risk None